This invention relates generally to devices and methods for generating volumes of space containing generally uniform static magnetic fields suitable for systemic treatment of an afflicted patient. More particularly, this invention relates to a device, and method of use therefor, which generates a substantially uniform static magnetic field in a sizeable volume of space defined in part by a plurality of DC electromagnetic coils, a method for systematically arranging and configuring these coils, and a patient supporting surface which may be placed therein and which an afflicted patient may be placed upon.
Throughout history, human beings have lived in an analog, rather than a digital world. Neither the sun nor the sundial kept precise time, but both were more than sufficient to fix dinnertime. Uniform likely once meant one part in ten or twenty, or one part in fifty or one hundred. A slide rule was, at best accurate to one part in one thousand, and was used for all but the most precise engineering and scientific work of its day. Applicant doubts that the basic human physiology or biology has changed much from then.
Although scientists disagree regarding what causes the earth""s magnetic field or the exact nature of the historical intensity changes of that field, there is general agreement that, in recent years, it has been decreasing. Some analysts conclude that the earth""s magnetic field has decreased 5% per century for at least the last 1000 years. If this rate of decline has been occurring over the 6000 years of history recorded in the Bible, it would indicate that the earth""s magnetic field at the time of Adam and Eve could have been as high as 20 gauss compared to the present 0.5 gauss geomagnetic field. Life spans recorded in the Biblical Chronology were at least an order of magnitude greater than they are today. Applicant believes that a more intense geomagnetic field may have been a contributory factor and that the recent measured decreases of geomagnetic field may be related to the increasing incidence of certain disease states. Research into the effects of magnetic fields upon living things began thousands of years ago and continues.
Recently, this research has primarily focused on the adverse effects of electromagnetic fields generated by A.C., and the therapeutic effects of permanent magnets used to treat specific localized afflictions. The fields of these magnets rapidly diminish with distance from the magnet. The actual field strength generated more than an inch or two from a typical permanent magnet, or a plurality of them is much weaker than the nominal strength of the magnet, and is quite nonuniform.
What appears to be a scholarly review of the history and current trends in biomagnetism appears at http://www.spot4u.com/post/doc.html. Extracts from this report appear below:
Beverly Rubik, Ph.D.xe2x80x94Chair, Robert O. Becker, M. D., Robert G. Flower, M. S., Carlton F. Hazlewood, Ph.D., Abraham R. Liboff, Ph.D., Jan Walleczek, Ph.D.
Bioelectromagnetics (BEM) is the emerging science that studies how living organisms interact with electromagnetic (EM) fields
All of the known frequencies of EM waves or fields are represented in the EM spectrum, ranging from DC (zero frequency) to the highest frequencies, such as gamma and cosmic rays. The EM spectrum includes x rays, visible light, microwaves, and television and radio frequencies, among many others. Moreover, all EM fields are force fields that carry energy through space and are capable of producing an effect at a distance.
Endogenous fields (those produced within the body) are to be distinguished from exogenous fields (those produced by sources outside the body). Exogenous EM fields can be classified as either natural, such as the earth""s geomagnetic field, or artificial (e.g., power lines, transformers, appliances, radio transmitters, and medical devices). The term electropollution refers to artificial EM fields that may be associated with health risks.
It is possible that the effects (both beneficial and harmful) of exogenous fields may be mediated by alterations in endogenous fields. Thus, externally applied EM fields from medical devices may act to correct abnormalities in endogenous EM fields characteristic of disease states.
Bone Repair
Three types of applied EM fields are known to promote healing of nonunion bone fractures (i.e., those that fail to heal spontaneously):
Pulsed EM fields (PEMFs) and sinusoidal EM fields (AC fields).
DC fields.
Combined AC-DC magnetic fields tuned to ion-resonant frequencies (these are extremely low-intensity, physically nonthermal fields) (Weinstein et al., 1990).
Approval of the U.S. Food and Drug Administration (FDA) has been obtained on PEMF and DC applications and is pending for the AC-DC application. In PEMF and AC applications, the repetition frequencies used are in the ELF range (Bassett, 1989). In DC applications, magnetic field intensities range from 100 microgauss to 100 gauss (G), and electric currents range from less than 0.1 microampere to milliamperes (Baranowski and Black, 1987). FDA approval of these therapies covers only their use to promote healing of nonunion bone fractures, not to accelerate routine healing of uncomplicated fractures.
Efficacy of EM bone repair treatment has been confirmed in double-blind clinical trials (Barker et al., 1984; Sharrard, 1990). A conservative estimate is that as of 1985 more than 100,000 people had been treated with such devices (Bassett et al., 1974, 1982; Brighton et al., 1979, 1981; Goldenberg and Hansen, 1972; Hinsenkamp et al., 1985).
Animal research in this area indicates that the body""s endogenous EM fields are involved in growth processes and that modifications of these fields can lead to modest regeneration of severed limbs (Becker, 1987; Becker and Spadero, 1972; Smith, 1967). Russian research and clinical applications, along with studies now under way in the United States, indicate that low-intensity microwaves apparently stimulate bone marrow stem cell division and may be useful in enhancing the effects of chemotherapy by maintaining the formation and development, or hematopoiesis, of various types of blood cells (Devyatkov et al., 1991).
The following studies are also relevant to the use of BEM for regeneration:
DC applications to promote rat spinal cord regeneration (Fehlings et al., 1992; Hurlbert and Tator, 1992).
Swedish work showing that BEM promotes rat sciatic nerve regeneration (Kanje and Rusovan, 1992; Rusovan and Kanje, 1991, 1992; Rusovan et al., 1992).
In wound healing and regeneration, repair of soft tissue and reduction of collagenous tissue in scar formation; regrowth via blastemal (primitive cell) formation and increase in tensile strength of surgical wounds; alleviation of decubitus chronic ulcers (bedsores); increased angiogenesis (regrowth of vascular tissue such as blood vessels); and healing of recalcitrant (i.e., unresponsive to treatment) chronic venous ulcers.
For instance, a short-term, double-blind clinical trial of magnetic field therapy could be based on the protocol of Trock et al. (1993) for osteoarthritis of the knee or elbow. This protocol is as follows:
A suitable patient population is divided into treatment and control groups. Individual assigmnents are coded and remain unknown to patients, clinicians, and operators until treatment and assessment are complete.
Pretreatment clinical markers are assessed by clinicians or by patients themselves or both.
Treatments consist of 3 to 5 half-hour sessions each week for a total of 18 treatments over 5-6 weeks.
During treatment, each patient inserts the affected limb into the opening of a Helmholtz coil (a solenoid about 12 inches in diameter and 6 inches long) and rests while appropriate currents are applied to the coil via a preset program.
The treatment is noninvasive and painless; the patient feels nothing; there is no measurable transfer of heat to the patient.
The control group follows the same procedure except that, unknown to operator and patient, a xe2x80x9cdummyxe2x80x9d apparatus (altered internally so that no current flows in the coil) is used.
Patients"" posttreatment clinical markers are assessed.
Appropriate data reduction (scoring of assessments, decoding of the treatment and control groups, and statistical analysis) is performed.
Clinical trials of BEM-based treatments for a variety of other conditions could follow a similar general outline.
In addition to the use of devices by practitioners, a plethora of consumer medical products that use magnetic energy are purported to promote relaxation or to treat a variety of illnesses. For example, for the bed there are mattress pads impregnated with magnets; there are magnets to attach to the site of an athletic injury; and there are small pellet-like magnets to place over specific points on the body. Most of these so-called therapeutic magnets, also called biomagnets, come from Japan. However, no known published journal articles demonstrating effectiveness via clinical trials exist.
BEM potentially offers a powerfull new approach to understanding the neuroendocrine and immunological bases of certain major medical problems (e.g., wound healing, cancer, and AIDS). However, substantial funding and time are required to perform the basic research needed in developing this approach.xe2x80x9d
For an example of a purportedly efficacious magnetic therapy device, applicant found the following; http://www.deslerent.com/magnets/12month.htm
xe2x80x9dThe mattress pads used in this study were typical full-size pads containing 124 permanent ferrite magnets with magnetic field strengths of 750-950 gauss each. The pads themselves were made of two sheets of felt with the magnets sandwiched between them. The felt sheets were then wrapped in a cloth cover. The total number of subjects in this double blind clinical experiment was 431 (216 male, 215 female). 375 subjects were given magnetic pads, 56 were given non-magnetic pads. None of the 431 subjects knew which pad they were sleeping on. Subjects selected for the experiment were those with chief complaints related to: Neck and Shoulder pain, Back and Lower Back Pain, Back Pain (general), Lower Limb pain, Insomnia and Fatigue. To determine the presence of any side effects, blood pressure, hemoglobin, number of erythrocytes and number of leucocytes were examined before and after the use of the mattress pads. Besides blood sedimentation, and TP, COL, ALT, GOT, GPT, Na, and K were also examined, as were functions of the kidneys, liver, pancreas, and the entire circulatory system.
Out of 375 total subjects with symptoms, 301 (80.27%) reported positive results. 74 cases (19.73%) reported no results
The percentage of subjects who realized the effect of the magnetic mattress pad within 3 days: Neck and Shoulder pain 46.9%, Back and Lower Back Pain 50%, Back Pain (general) 38.7%, Lower Limb pain 54.4%, Insomnia 64.3% and Fatigue 57.8%. Out of 375 total subjects who slept on magnetic mattress pads, 200(53.3%) realized the effects within 3 days. Over 70% realized the effects within 5 Days.
Testing for side effects was conducted at the conclusion of the experiment. Symptoms such as tinnitus, headache, hearing problems, visual disturbances, vertigo, palpitation, perceptive abnormality, motor disturbance, fever, digestive disturbance, cutaneous symptoms, and other clinical symptoms to suggest any side effects were found to be totally absent. Extensive testing was also done before and after the experiment to check functions of the kidney, liver, pancreas, blood pressure, and circulatory system. No clinical symptoms were found to indicate any side effects whatsoever.
Dr. Shimodaira""s conclusion of this year long study conducted in 3 of Japan""s foremost hospitals: xe2x80x9cThe magnetized health mattress (pad) is proved to be effective on neck and shoulder pain, back and lower back pain, back pain, lower limb pain, insomnia and fatigue, and to have no side effects.xe2x80x9d
Applicant has so far been unable to locate any other report on this study. Another apparent problem with this device is the lack of uniformity in field strength. A veterinary magnet was evaluated. Magnetic field strength is measured in one of two units: 1 Tesla=104 (Gauss. The magnetic field strength of a Norfield""s MAGNETIC hockwrap(trademark) (for horses) measured at California Institute of Technology had field strength of 270 Gauss at the level of the pad and 1 Gauss at a distance of 1 cm from the pad. This article was located at http://www.hcrc.org/contrib/ramey/magnet.html Plainly, the mattress pad described above has anything other than a uniform static magnetic field. Further, the average field strength is likely to approximate 1 Gauss or less.
The generation of static magnetic fields of more than moderate size has also been a daunting task. Pairs of DC electric coils known as Helmholtz coils have long been known to be capable of generating limited volumes of space having uniform magnetic fields, as is well known in the art. However according to the prior art, these coils must comply with relatively stringent requirements. The coils must be of equal size, r, be identical, carry the same current, and be separated by the distance r. If those conditions are met, an axially uniform static magnetic field may be generated in some portion of the volume between the coils; this field is known to be substantially uniform along this axis.
Those machines known as NMR machines apparently have the ability to generate uniform magnetic fields over a volume having a radius on the order of 50 cm. However these fields are designed for the chemical analysis of inanimate samples, not for the possible systemic application of a uniform static magnetic field to a living subject.
From the foregoing several facts emerge. There are some reported therapeutic benefits from static magnetic fields. However there has been little use of large-scale substantially uniform static magnetic fields, as their generation has been problematic at best. The primary method of creating any semblance of such a field has been through the Helmholtz coil, which, a] is subject to restrictive conditions, and b] generates an axially substantially uniform field in a relatively small volume of space.
U.S. Pat. No. 5,935,516, to Baugh, teaches an air-tight chamber for placement of plants, animals, raw materials, and other items. The reference also teaches the use of a single shielded coil surrounding or lining the inside of the chamber to establish an AC-powered, variable magnetic field within the chamber of a predetermined strength and orientation. There is no indication that the reference, which teaches oscillating the magnetic field at a frequency of 0.5 to 30 Hz, is operable to produce a substantially uniform static magnetic field. Moreover, the apparatus taught is not advantageously disposed for use on patients because of the difficulty of entering or exiting the chamber and because the use of a single coil wound about the entire length of the chamber would tend to obstruct access to the patient.
What is needed is an apparatus for generating a large-scale uniform static magnetic field having a substantial volume large enough to accommodate a resting surface capable of comfortably accommodating an adult human being, which could be contained there within. What is also needed is a systemized method for arranging and configuring DC powered coils to create such fields. It is towards filing these needs that the present invention is directed.